Street Calls of the Week
BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX), a $3.02 billion market cap pharmaceutical company that has seen its stock rise 21% year-to-date, announced Friday it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for a proposed biosimilar to Xolair (omalizumab), a treatment for asthma and other conditions.
The submission came earlier than expected for the biosimilar, which was developed by Kashiv BioSciences, LLC. Amneal holds exclusive U.S. commercialization rights for the product, pending regulatory approval.
Omalizumab is indicated for treating moderate to severe persistent asthma in patients 6 years and older, chronic rhinosinusitis with nasal polyps in adults, food allergies in patients over 1 year old, and chronic spontaneous urticaria in patients 12 years and older.
"We are excited about the opportunity to be part of the first wave of omalizumab biosimilars in this large and attractive market," said Andy Boyer, Executive Vice President and Chief Commercial Officer of Affordable Medicines at Amneal.
According to IQVIA data cited in the company’s press release, U.S. annual sales for Xolair totaled approximately $4.1 billion for the 12 months ending July 2025. With Amneal’s revenue growing at 9.81% and maintaining a GREAT financial health score according to InvestingPro analysis, this market opportunity could significantly impact the company’s future growth trajectory. InvestingPro subscribers can access 8 additional key insights about Amneal’s growth potential and financial stability.
The earlier BLA filing will cause Amneal to incur a $22.5 million research and development milestone charge in the third quarter of 2025 instead of the fourth quarter as previously expected. The company stated this cost was included in its financial guidance.
Amneal currently markets three biosimilars and expects to launch five more between 2026 and 2027, including this Xolair biosimilar.
Xolair is a registered trademark of Novartis AG.
In other recent news, Amneal Pharmaceuticals reported its second-quarter 2025 earnings, revealing earnings per share (EPS) of $0.25, which exceeded analysts’ expectations of $0.17. Despite this earnings beat, the company’s revenue fell short of forecasts, reporting $725 million against the anticipated $748.18 million. Additionally, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration approved its Abbreviated New Drug Application for bimatoprost ophthalmic solution 0.01%, a generic version of Allergan’s Lumigan, used for treating open-angle glaucoma and ocular hypertension. In another development, the FDA also approved Amneal’s risperidone extended-release injectable suspension, a generic alternative to Janssen’s Risperdal Consta, for treating schizophrenia and as maintenance therapy for Bipolar I disorder. These recent developments highlight Amneal’s continued expansion in generic pharmaceuticals.
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